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FDA 510(k), K021144, SUBDURAL STRIP ELECTRODE
FDA 510(k), K021144, SUBDURAL STRIP ELECTRODE
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510(K) Number: K021144
Device Name: SUBDURAL STRIP ELECTRODE
Manufacturer: NICOLET BIOMEDICAL, INC.
Device Classification Name: electrode, cortical
Regulation Number: 882.1310
Classification Product Code: GYC
Date Received: 04/09/2002
Decision Date: 06/24/2002
Regulation Medical Specialty: Neurology
Device Name: SUBDURAL STRIP ELECTRODE
Manufacturer: NICOLET BIOMEDICAL, INC.
Device Classification Name: electrode, cortical
Regulation Number: 882.1310
Classification Product Code: GYC
Date Received: 04/09/2002
Decision Date: 06/24/2002
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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